UK CBD Law – An In-Depth Analysis
This In-depth Analysis of CBD Law In the United Kingdom was developed to help both consumers understand what is required of the CBD products they consume to be legal and for brands navigate the many legal barriers to entry into the UK CBD Market.CBD Law in the UK is quite complex and constantly evolving. It is essential to us here at Bloom Botanics to make sure that we are up to date on the current legal status of CBD and cannabis/hemp extracts. This is to ensure that we are selling our customers legal and lab-tested products in the UK. Keeping ourselves and our customers legally safe.
– Bloom Botanics Team
Table of Contents:
- Introduction: Relevant Laws.
- Is CBD a Scheduled potentially illegal non-ethical drug in the United Kingdom? (In many cases, this is likely the case.)
- Is CBD a medicine in the UK and, therefore, regulated as a medicine? (In many cases, this may well be likely)
- CBD and issues regarding “Cannabis-Based Products for Medicinal Use in Humans (CBPM)s –Regulation 2 and Schedule 2 MDR 2001” (This generally does not refer to pure CBD. In fact, at this time, in the UK it is also not relevant to CBD in a format which includes any amount of THC, and has not been approved as a drug, or is not prescribed by a specialist physician)
- CBD as a food or food supplement in the United Kingdom
- The Centre for Medicinal Cannabis
1. Introduction: Relevant Laws:
Pure CBD appears excluded from being a controlled drug in the UK. However, a multitude of specific laws and regulations must be followed and further, the CBD product can contain in total no more than 1 mg of THC, which is essentially zero concentration by weight.
Class A Drugs are controlled under various acts in the United Kingdom including the Misuse of Drugs Act 1971. The 1971 Act applies to “Controlled Drugs”. This includes substances or products specified in Schedule 2 to the Act.
That Schedule divides controlled drugs into one of three classes: A, B and C – broadly based on their relative harms, with Class A drugs considered the most harmful. Examples of each class of drug are:
- Class A – Cocaine, Fentanyl, Opium (raw, prepared, or medicinal);
- Class B – Amphetamine, Codeine, any ester or ether of Cannabinol or of a Cannabinol Derivative, Cannabis and Cannabis Resin, and ketamine;
- Class C – Clobazam, khat, and temazepam.
“Cannabinol derivatives” means, except where contained in cannabis or cannabis resin, tetrahydro derivatives of cannabinol and 3-alkyl homologs of cannabinol or of its tetrahydro derivatives”. Cannabis Oil is also considered “Class B“.
Regarding definitions of terms, it should be noted that in biologically (concepts and terms of which are applicable legally, unless specifically redefined under legislation or related regulations) Hemp Plants are in the Cannabis Sativa species and therefore are Cannabis.
2. Is CBD a Scheduled potentially illegal non-ethical drug in the United Kingdom?
Please note that the term “ethical drug“ is defined to be a prescription drug that is only available with written instructions from a doctor or dentist to a pharmacist. Based on the review of the Home Office documentation, all referenced below, one could conclude that CBD is a Class B controlled drug, however, legal opinions are being offered that pure CBD is excluded from the Misuse of Drugs Act.
Suggested Reads: Field fisher, 10 Things you should know about Medicinal Cannabis in the UK & Reed Smith LLP, “Cannabis in the UK – a regulatory environment in transition?” & Home Office Interpretation of Legislation and Regulations Regarding Cannabis, CBD, and Other Cannabinoids
The following views are extracted from Drug Licensing Factsheet – Cannabis, CBD and other Cannabinoids, published on the worldwide web and dated August 26, 2019. The Government preamble to the Guidance, called ““Cannabis, CBD and other cannabinoids: drug licensing factsheet” states: “This factsheet outlines the domestic control measures that apply to cannabis, cannabidiol (CBD) and controlled cannabinoids.” According to the UK government statements on the web at that location:
“This factsheet is intended to be used by existing licensees and prospective licensees who may need to apply for a licence. They should have fully assessed any proposals they may wish to make in the context of this guidance and that provided by other regulators.”
“ This is intended as general guidance only; it is not legal advice. Anyone in doubt should seek their own independent legal advice to ensure they are compliant with any relevant legislation.”
“This factsheet represents the Home Office’s view on the domestic control measures applicable to cannabis, cannabidiol (CBD) and controlled cannabinoids. It is intended as a resource for existing licensees and prospective licensees who may need to apply for a licence, having fully assessed any proposals they may wish to make in the context of this guidance and that provided by other regulators.”
“There are two separate licensing regimes relating to cannabis cultivation, according to whether the varieties are high or low THC (as differentiated in the Misuse of Drugs (Fees)
Regulations 2010). This factsheet may also be read in conjunction with published guidance relating to low- THC Industrial Hemp cultivation and use of non-controlled hemp products from fibre and seed is available at https://www.gov.uk/government/collections/drugs-licensing#industrial-hemp.
Home Office General Legislative Position on Cannabis and “Cannabis-based products for medicinal use in humans”:
“Cannabis is a Class B controlled drug under Part II, Schedule 2, of the Misuse of Drugs Act 1971 (MDA 1971). It is also listed in Schedule 1 to the Misuse of Drugs Regulations 2001 (MDR 2001) and designated under the Misuse of Drugs (Designation) (England, Wales and Scotland) Order 2015 (2015 Order). As such, it is unlawful to possess, supply, produce, import or export this drug except under a Home Office licence. It is also an offence to cultivate any plant of the genus Cannabis except under a Home Office licence.”
The Misuse of Drugs Regulations 2001 is located at www.legislation.gov.uk/uksi/2001/3998/regulation/2/made.
The regulations are with respect to the Misuse of Drugs Act 1971. The Regulations are also at www.legislation.gov.uk/uksi/2001/3998/pdfs/uksi_20013998_en.pdf.
“Cannabis-based products for medicinal use in humans” (“CBPM”) -a defined category of cannabis, cannabis resin, cannabinol and cannabinol derivatives -are listed in Schedule 2 to the MDR 2001 and removed from designation under the 2015 Order.”
Under Schedule 1 to the 2001 Regulations are included: Cannabinol, Cannabinol derivatives not being dronabinol and its isomers, and cannabis resin, and their isomers, esters, and salts, and any preparation of other products containing such substances except as excluded in Schedule 5.
Based on the analysis below, and additional analysis regarding hemp (further below) it would seem that selling pure CBD, but not as a medicine, but in conjunction with some carrying substance, could be legal in the UK. Related factors include the source of the CBD, whether it is regarded as a food
According to the Home Office Statement:
“CBD as an isolated substance, in its pure form, would not be controlled under the MDA 1971 / MDR 2001.”
“If a CBD ‘product’ contained any controlled cannabinoids, unintentionally or otherwise (e.g. THC or THC-V), then it is highly likely that the product would be controlled. It is our understanding that it is very difficult to isolate pure CBD, and in our experience many products in fact do not fully disclose their contents or provide a full spectrum analysis at an appropriate
level of sensitivity to accurately and consistently determine their true content or control status”.
“Against this background, the presumption has to be one of caution -that is, that a CBD containing product would be controlled under the MDA 1971 / MDR 2001 as a result of its other cannabinoid content.”
“In addition to any issues associated with controlled substance content, cannabis/ cannabis extract products may also need to satisfy other regulatory requirements if clinical/medicinal benefits are claimed. In this respect, companies may wish to contact the MHRA for their view on whether the cannabis/ cannabis extract products are additionally subject to their licensing regime and control.”
The Home Office Statements also includes the following:
“For a CBD and other cannabinoid products to be lawfully available for human consumption, it needs to either meet the Exempted Product Criteria in Regulation 2 of the MDR 2001 or the definition of a CBPM in Schedule 2 to the MDR2001 for its possession to be lawful.”
“Where a product is neither a CBPM nor an ‘Exempted Product’, licenses would not ordinarily be issued to enable the use of a ‘Schedule 1’ controlled drug product outside of bonafide research or a recognised UK clinical trial.”
“The ‘exempted product’ definition -Regulation 2 of the MDR 2001”
Regulation 2 (Interpretation) to the Misuse of Drugs Act 1971 “provides that some products may, in limited circumstances, be considered ‘exempt’ from control, notwithstanding their ‘controlled drug’ content.”
“The regulation sets out: An “exempt product” means a preparation or other product consisting of one or more component parts, any of which contains a controlled drug, where—
- the preparation or other product is not designed for administration of the controlled drug to a human being or animal;
- the controlled drug in any component part is packaged in such a form, or in combination with other active or inert substances in such a manner, that it cannot be recovered by readily applicable means or in a yield which constitutes a risk to health; and
- no one component part of the product or preparation contains more than one milligram of the controlled drug or one microgram in the case of lysergide or any other N-alkyl derivative of lysergamide.”
“To meet the criteria of an exempted product all three limbs of the definition must be met.”
“The Home Office view is that this definition may apply to drug preparations or products in any form-for example an Active Pharmaceutical Ingredient (API) or a medicinal product in Finished Dose Form (although it is highly likely that in a ‘bulk form’ the 1mg threshold would cease to be met).”
“It is the Home Office view that, to establish that the definition is met, testing e.g. a full spectrum analysis to the appropriate threshold by an independent and licensed UK company, and provision of comprehensive and independently verifiable information and research of an appropriately rigorous nature will be required. It is likely that the product will be subjected to regulation as a medicinal product (or to an equivalent UK regulatory standard) as a way of demonstrating that there is no intention of administering the controlled drug element of the product (referred to in (a)). The purpose and intended method of administration of a product may affect this. It is the Home Office view that the applicable unit of measure for the 1mg ‘threshold’ referred to in (c) is that of the ‘container’ (i.e. bottle or packet) and not the ‘typical dose’ (of any product).”
Conclusions regarding CBD Products Being a Controlled Drug:
I have drawn considerably from ReedSmith Pepper and Perry 2019 Client Alert .
Pure CBD is not a controlled drug under the Act or the Regulations. However, the Home Office’s position appears to be that it is very difficult to isolate pure CBD and remove any controlled cannabinoids, such as THC. The presence of THC (even in very small quantities) is highly likely to mean that CBD products intended for human or animal administration are controlled under both the Act and the Regulations. Thus, the Home Office’s approach seems to be that a Home Office license would be required to import, export, produce, supply or possess CBD products.
It is often stated on the web in “lay” commercial articles that CBD oil products with a THC content of less than 0.2% are legal and by implication that they may not require a Home Office license. This is totally false. The assertions confuse legally acceptable CBD product definitions with the laws related to the definition of hemp plants, for the purpose of obtaining licenses to grow hemp.
3. Is CBD a medicine in the UK and therefore regulated as a medicine?
Even if a CBD-containing product is not subject to the controls of the Act or the Regulations, the UK’s medicines and medical devices regulator, the Medicines & Healthcare products Regulatory Agency (MHRA), has taken the view that “products containing cannabidiol (CBD) used for medical purposes are a medicine” and as such must have an MHRA product license (marketing authorization) before being made available to consumers, supplied or advertised unless they fall under the narrow exemptions of the Human Medicines Regulations 2012 (the exemptions
now include “CBPMs” (see below), subject to certain controls). To date, only one cannabis-based medicinal product, Sativex, (for the treatment of multiple sclerosis) has been licensed by the MHRA.
The MHRA has issued new guidance on Cannabidiol in October of 2018, ‘Guide to what is a Medicinal Product’. This is a primary document for products that fall within the borderline area. It sets out MHRA thinking based on new legislation and cases they have assessed. The MHRA does not state if a category is or is not legal, as it assesses any specifics based on the specifics of that defined product.
The Guide refers to virtually all relevant aspects of possible CBD product regulation as a medicine, food, food supplement, cosmetics, etc. However, its details only relate to medical product regulation.
In the October 2018 revised MHRA guide the changes are presented in Appendix 10, page 67. This appendix covers the MHRA position/guidance for Cannabidiol containing products, covering:
- CBD products for non-medical purposes;
- Compliance with other regulatory frameworks; and
- CBD products for medical purposes, including supply of an unlicensed medicine
(“a special”), and licensing.
According to the MHRA Guidelines as to what are medical products, “to protect public health, and on behalf of the UK Licensing Authority, the Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicinal products for human use in accordance with the European Community’s medicinal products directive (Directive 2001/83/EC, as amended, “the Directive”) and UK law. The MHRA may be asked to give an opinion on, or make a formal determination on whether a product is or is not a medicinal product. This is a specialist function carried out by classifiers in the MHRA’s Medicines Borderline Section. If a classifier does decide that a product is a medicinal product, then unless an exemption applies, it will be subject to the Human Medicines Regulations 2012 [SI 2012/1916] (“the Regulations”).”
“The person or company marketing a product has a responsibility to do so in accordance with the law. The Regulations provide that, unless exempt1, any medicinal product placed on the UK market must have a marketing authorisation (MA), traditional herbal registration (THR) or certificate of registration as a homoeopathic product granted by the European Commission or by the UK Licensing Authority. A marketing authorisation or registration is only granted for a medicinal product which meets statutory standards of safety, quality and efficacy, whilst products registered as traditional herbal medicines or as homoeopathic medicines have to meet statutory standards of safety and quality. Traditional herbal medicinal products are required to demonstrate plausible efficacy alongside other criteria. See Section 9 of this guidance note for further information on this aspect.”
MHRA – Borderline Products:
“The regulatory status of products on the borderline between medicinal products and food supplements, biocides, cosmetic products, medical devices or ‘general products’ may not be immediately obvious. This Guidance explains how, and on what basis, the MHRA decides whether products are medicines or not and clarifies the MHRA’s position on traditional herbal medicinal products.”
Click here to view the detail of approved products.
“The MHRA, on behalf of the UK Licensing Authority, determines (subject to review by the courts), whether a product is a medicinal product. The MHRA’s power to determine the status of a product as a medicinal product has been confirmed following a judgment of the Court of Appeal (R. v. Medicines Control Agency ex parte Pharma Nord (UK) Limited 1998). The Court ruled that it was acceptable for the Licensing Authority to determine whether or not a product is a medicinal product, having expert knowledge, the decision of the Licensing Authority being subject to review by the courts. This authority is also cited in subsequent litigation cases.”
A medicinal product is defined as: “any substance or combination of substances presented as having properties for treating or preventing disease in human beings; [the first/presentational limb]” or “any substance or combination of substances which may be used in, or administered to, human beings, either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis” [the second/functional limb]”.
“The Food Information to Consumers Regulation (FIC) (Regulation (EC) 1169/2011), contains provisions for both the labelling and advertising of food. In particular, any claim that a food has the property of preventing, treating or curing human disease is not permitted. This covers any implication that a foodstuff is capable of protecting against or relieving the symptoms of, disease, infection or other adverse conditions. The MHRA must, therefore, be mindful of the primary purpose of the product when investigating whether medicinal claims which are made for food products (including food supplements) should be subject to the Regulations. In addition, any nutrition or health claims made on food must now be authorized before use in the EU. The Nutrition and Health Claims Regulation (Regulation (EC) 1924/2006), sets out the requirements for authorization of claims for foods and the European Commission has established a register of permitted, rejected and pending nutrition and health claims.
“A product which the average consumer would regard as something to be eaten, drunk or chewed as part of a diet, because of its taste, flavour, or nutritional value etc., is unlikely to be classified by the MHRA as a medicinal product unless it contains one or more ingredients generally regarded as medicinal and indicative of a medicinal purpose. If the MHRA determines
that such a product is not a medicine, it is likely to be regulated under food law. However, a product which satisfies equally well the conditions for classification as a food and the conditions for classification as a medicinal product will generally be classified as a medicinal product taking into account all of the product’s characteristics.”
“The European Commission has issued specific guidance for food supplements in relation to the applicability of Regulation (EC) 764/2008, which concerns mutual recognition in the EU. This guidance is helpful in relation to borderline products, noting that there may be instances where a product is regarded to be a food supplement in one Member States and a medicinal product in another.”
Cannabis-based products for medicinal use in humans:
“Cannabis-based products for medicinal use in humans” (“CBPM”) -a defined category of cannabis, cannabis resin, cannabinol and cannabinol derivatives -are listed in Schedule 2 to the MDR 2001 and removed from designation under the 2015 Order.”
Under Schedule 1 to the 2001 Regulations are included: Cannabinol, Cannabinol derivatives not being dronabinol and its isomers, and cannabis resin, and their isomers, esters, and salts, and any preparation of other products containing such substances except as excluded in Schedule 5.
Appendix 10 to the Guidance, called “Guidance on Cannabidiol (CBD) Products” is presented directly below:
“In 2016 MHRA published an opinion that products containing CBD, when used for a medical purpose, should be regulated as medicinal products (https://www.gov.uk/government/news/mhra-statement-on-products-containing-cannabidiol-cbd ). The MHRA’s opinion was issued with the intention of seeking voluntary compliance by companies supplying CBD for medical purposes. This guidance has been published in response to a significant number of requests for regulatory advice regarding the sale of CBD products for non-medical purposes and is intended to supplement MHRA’s published opinion.”
“In the UK, as in the rest of the EU, medicinal products which are placed on the market, are required to have marketing authorizations in accordance with The Human Medicines Regulations 2012 (S.I. 2012/1916) (the Regulations). Amongst other things these provide that, unless exempt, no medicinal product shall be placed on the market unless an appropriate authorization has been granted in accordance with EU law by the licensing authority or the European Commission.”
“It is an offence to sell or supply or to advertise a medicinal product which does not have authorization. A “medicinal product”
is defined in Article 1 of Directive 2001/83/EC, which is implemented by Regulation 2 of the Regulations. The definition, which is in two ‘limbs’ is:
“Any substance or combination of substances presented as having properties for treating or preventing disease in human beings (Limb 1). Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis (Limb 2).”
“If a product satisfies either of the above criteria, it may be classed as a medicinal product. In broad terms, when classifying a product, the Agency looks at the way it is presented and its function, that is, its effects (when administered) on human physiology. The term “disease” is defined in Regulation 8 of the Regulations as: “includes any injury, ailment or adverse condition, whether of body or mind”. Where unauthorized products are marketed for a medical purpose MHRA will take appropriate action to achieve compliance. Where necessary, MHRA can use the statutory determination process described in Appendix 3 of this Guidance to formally classify a particular product. Any product that makes a medicinal claim would fall within Limb 1 of the definition. For the avoidance of doubt, this includes any testimonies that are included on websites or any other promotional material. Further guidance in relation to medicinal claims can be found in Appendices 1, 8 and 9 of this guidance.”
“It is a matter of fact that there have been a number of clinical trials which demonstrate that CBD has a therapeutic effect, particularly in the treatment of severe epilepsy. MHRA’s clinical assessors have reviewed relevant scientific and clinical evidence to support the mode of action of CBD in the treatment of a range of medical conditions. It should also be noted that the European Medicines Agency has given CBD products an orphan designation on four occasions, for three different clinical conditions; graft versus host disease, perinatal asphyxia and Dravet syndrome. An application for a CBD product (Epidiolex) is currently under assessment within the EU for use as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients from 2 years of age.”
CBD products for non-medical purposes:
“The emerging evidence of clinical efficacy outlined above MHRA could, in future, regard certain CBD products, which may currently be marketed under other regulatory frameworks, to fall within the second limb of the definition of a medicinal product. Given this, MHRA can give no assurance that any particular product, including products under development, will not subsequently be classified as a medicinal product. Classification as a medicinal product overrides other regulatory frameworks and it is important that a company considering the marketing of CBD products as a non-medicine should be aware that the regulatory status of their product may change.”
Compliance with other regulatory frameworks:
“MHRA will never advise that a product is ‘legal’. This is because our remit is limited to the regulation of medicines and medical devices and any advice given in relation to CBD products will be in respect of classification as a medicinal product. Products which are not deemed to be medicines will be subject to other regulatory frameworks and it is the responsibility of those who manufacture and/or market a product to ensure that it complies with the relevant legislation. MHRAs encourage companies to seek advice from the relevant authorities.”
“Local Authority Trading Standards or Environmental Health Departments can advise on relevant aspects of food law (including food supplements). This may include, but not be limited to, registration as a food business operator, compliance with food hygiene regulations and products which might be regarded to be novel foods.”
“Products containing CBD that are intended to be placed in contact with the external parts of the human body with a view exclusively or mainly to fulfil a cosmetic function as per article 2 of the Cosmetic Products Regulation (EC) 1223/200913 must meet the regulatory requirements set out by this Regulation. Regulation (EC)1223/2009 ensures the safety of cosmetic products, their cosmetics ingredients (irrespective of their source) and protect consumers from misleading claims.”
“MHRA is occasionally asked whether claims can be made for CBD in respect of the endocannabinoid system. The endocannabinoid system is a neuromodulator system that has a role in central nervous system development and in regulating a variety of physiological and cognitive processes.”
“Claims which imply that CBD can modify, stimulate or enhance the endocannabinoid system (or similar) may in context, be regarded to be medicinal claims. Where claims are not regarded to be medicinal claims, companies are advised to be mindful of health claims legislation which applies to foods (Regulation (EC) 1924/200614) and/or check with Trading Standards or Environmental Health to see whether they can be used without prior approval.”
“Companies should be mindful that if products contain other cannabinoids, including at low levels, these may be regarded to be controlled substances. The Home Office has issued a factsheet, called ‘Cannabis, CBD and other cannabinoids’ which sets out the Exempted Product Definition and how these products should be regulated.
This can be accessed at the following website: https://www.gov.uk/guidance/controlled-drugs-licences-fees-and-returns .”
CBD Products for Medicinal Purposes:
“In the absence of any licensed CBD medicinal products, MHRA would advise individuals with underlying medical conditions who are using CBD to discuss this with their doctor who may prescribe medicinal products to appropriately manage the symptoms. Companies wishing to supply CBD products for a medical purpose should consider the following”:
“(i) Supply of an unlicensed medicine (a ‘Special’)”
A medicine is generally required to have a marketing authorization (product license) before being placed on the market. However, unlicensed medicinal products containing CBD could be made available to individuals on prescription, but this supply is subject to certain conditions. An unlicensed medicine can only be supplied to meet the special needs of an individual patient. Responsibility for deciding whether an individual patient has “special needs” (interpreted as clinical needs) which a licensed product cannot meet should be a matter for the prescriber responsible for the patient’s care. An unlicensed medicine may not be advertised, a manufacturer, importer or wholesaler may provide factual responses related to the supply of products but these cannot include medicinal claims. See MHRA Guidance Note 14 for further information regarding the sale and supply of unlicensed medicines. https://www.gov.uk/government/publications/supply-unlicensed-medicinal-products-specials “
“(ii) Obtaining a license to supply a licensed medicine”
“For general information on licensing applications, please refer to www.gov.uk/medicines-medical-devices-blood/marketing-authorisations-variations-licensing; https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk. “
“Our Regulatory Information Service can also advise on how to submit new license applications on Tel: 020 3080 7400 or via email at [email protected] Where CBD is being considered for a clinical trial in humans (an MHRA responsibility) the material will need to be manufactured or imported by the holder of the appropriate manufacturer’s authorization for an investigational medicinal product, [known as an MIA(IMP)] and have a clinical trial authorization (CTA). These links may be helpful: www.gov.uk/government/collections/clinical-trials-for-medicines www.gov.uk/guidance/medicines-get-scientific-advice-from-mhra “
“This guidance sets out MHRA’s current position in respect of the classification of CBD products. It also briefly covers the supply of CBD products as medicines. Companies need to be mindful of MHRA’s remit and ensure that they have obtained advice from all relevant regulators prior to placing products on the market.”
4. CBD and issues regarding “Cannabis Based Products for Medicinal Use in Humans (CBPM)s –Regulation 2 and Schedule 2 MDR 2001”
As previously stated and quoted from the Home Office Factsheet, “ for a CBD and other cannabinoid products to be lawfully available for human consumption it needs to either meet the Exempted Product Criteria in Regulation 2 of the MDR 2001 or the definition of a CBPM in Schedule 2 to the MDR2001 for its possession to be lawful. Where a product is neither a CBPM nor an ‘Exempted Product’, licences would not ordinarily be issued to enable the use of a ‘Schedule 1’ controlled drug product outside of bona-fide research or a recognised UK clinical trial.”
Regulation 2 and Schedule 2 MDR 2001:
“With effect from 1 November 2018, CBPMs will be listed in Schedule 2 to the MDR 2001.”
“Regulation 2 of the MDR 2001 http://www.legislation.gov.uk/uksi/2018/1055/contents/made defines CBPMs as: “cannabis-based product for medicinal use in humans” means a preparation or other product, other than one to which paragraph 5 of part 1 of Schedule 4 applies, which—
- is or contains cannabis, cannabis resin, cannabinol or a cannabinol derivative (not being dronabinol or its stereoisomers);
- is produced for medicinal use in humans; and
- is (i) a medicinal product, or (ii) a substance or preparation for use as an ingredient of, or in the production of an ingredient of, a medicinal product.”
“A CBD preparation or product containing controlled cannabinoids (e.g. THC) which meets the three limbs of this definition may be a CBPM.”
“Specialist Doctors can prescribe CBPMs without requiring a Home Office licence to lawfully write a prescription. However, as with other controlled drugs in Schedule 2, companies wishing to possess, supply, produce, manufacture and/ or import/ export these products will require Home Office Controlled Drug licences to lawfully undertake these activities, unless a limited licensing ‘exemption’ applies -e.g. a pharmacist or person conducting a retail pharmacy business acting in their respective capacities (however see guidance here on wholesale dealing: https://www.gov.uk/guidance/controlled-drugs-licences-fees-and-returns). It should be noted that Regulation 16A of the MDR 2001 imposes additional controls for the order and supply of CBPMs for the purpose of administration.”
“Where a preparation or product containing cannabis, cannabis resin, cannabinol or a cannabinol derivative does not meet the definition of a CBPM, it will be a Schedule 1 drug under the MDR 2001 unless the exempt product definition applies. “
5. CBD as a Food or Food Supplement in the United Kingdom:
The EU publications regarding CBD as a novel food has been relevant to food authorities in the United Kingdom. According to the law firm Arnold and Porter in EU Regulation of CBD in Foodsand Cosmetics August 15 2019, the EU position (As of 1 January 2018, the new Regulation (EU) 2015/2283 on novel foods (the Novel Food Regulation) is applicable. It repeals and
replaces Regulation (EC) No 258/97 and Regulation (EC) No 1852/2001 which were in force until 31 December 2017) is “Under European Union law, food that has not been consumed to a significant degree by humans in the EU before 15 May 1997, when the first Regulation on novel foods came into force, is considered as “Novel Food” and controlled in a stricter manner than regular foods under Regulation (EU) 2015/2283 (“the Novel Food Regulation”).”
“Food producers can place a Novel Food on the EU market only after the European Commission has processed an application for the authorisation of the novel food, has adopted an implementing act authorising its placing on the market and updated the EU list of novel foods.”
“A food or ingredient will be authorised only if it meets the criteria laid out in Article 7, namely it is shown to be safe, not nutritionally disadvantageous and does not mislead the consumer.”
“There are three routes by which an apparently novel food may be approved or authorised under the Novel Food Regulation:
- by showing the food’s significant history of use in the EU prior to 1997, through the official consultation procedure provided for in Article 4 (i.e. that the food or ingredient is not, in fact, a Novel Food); or
- as a traditional food from a third country in accordance with Article 15, where a history of safe food use for at least 25 years can be demonstrated; or
- a full application based on submission of a dossier for registration of a Novel Food in accordance with Articles 10-13.”
“The EU Novel Food Catalogue lists foods and ingredients viewed as novel foods, for which an authorisation should be obtained. The Catalogue itself, has no legal status, but is frequently used by EU Member States to assist in enforcement of the Novel Food Regulation.”
“The cultivation of Cannabis sativa L. varieties is permitted in the EU provided they are registered in the EU’ The European Commission’s Working Group of Novel Foods has recently reclassified CBD as a Novel Food for the purposes of the EU Novel Food Catalogue.”
This currently states in relation to Cannabis sativa L.” “Some products derived from the Cannabis sativa plant or plant parts such as seeds, seed oil, hemp seed flour, defatted hemp seed have a history of consumption in the EU and therefore, are not novel. Other specific national legislation may restrict the placing on the market of this product as a food or food ingredient in some Member States. Therefore, it is recommended to check with the national competent authorities”.
“The entry for cannabinoids now states: ‘[…] extracts of Cannabis sativa L. and derived products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated. This applies to both the extracts themselves and any products to which they are added as an ingredient (such as hemp seed oil). This also applies to extracts of other plants containing cannabinoids. Synthetically obtained cannabinoids are considered as novel’.”
“As a result of this change, the European Commission now regards all extracts of hemp and derived products containing cannabinoids (including CBD) as novel. Hemp seeds, flour and seed oil remain excluded from the categorisation of Novel Foods in the Catalogue, as long as cannabinoids have not been added as ingredients. While, as stated above, the Catalogue has no legal status, in practice it will be given substantial weight by national authorities, who may therefore conclude that foods containing CBD may be placed on the EU market only once an authorisation under the Novel Foods Regulation has been obtained. Nevertheless, the current approach to CBD, at Member State level, following the amendment to the Novel Foods Catalogue, is variable:”
“The Irish Food Safety Authority considers CBD products based on the manufacturing process applied. CBD oil prepared through cold-pressing of hemp seeds, may be sold on the basis that this oil contains low levels of CBD. In contrast, CBD obtained through methods such as supercritical CO2 extraction, would be viewed as Novel Foods for which an authorisation is required. Other authorities (e.g. those in Belgium and Austria) do not permit CBD products to be marketed.”
“A novel food application for CBD is currently under consideration with the European Food Safety Authority (EFSA) to authorise the use of CBD in food supplements for adults with a daily intake of up to 130 mg. This application was made by Cannabis Pharma s.r.o., a company from the Czech Republic and is based on publicly available safety and toxicological information and toxicity reviews. The opinion of the EFSA is reportedly expected soon. This decision will be closely monitored by the industry as it may have wider significance for the CBD food products market. CBD food products lawfully on the market prior to 1 January 2018 may rely on the transitional provisions of the Novel Foods Regulation. As long as an application for an authorisation is filed before 2 January 2020, the product can continue to be marketed until an authorisation decision has been taken by the Commission.”
“The status of foods containing CBD also determines the claims that may be made when they are marketed. If such products qualify as foods or food supplements, only specific health or nutrition claims authorised in the EU Register in accordance with Regulation (EC) No 1924/2006 may be made. Any CBD product taken for a medical purpose and associated with medical claims must be authorised as medicinal products.“
The current position of the United Kingdom Food Standards Agency (last updated on the web, May 2018) appears to be “The FSA accepts the clarification from the EU that CBD extracts are considered novel foods. We are committed to finding a proportionate way forward by working with local authorities, businesses and consumers to clarify how to achieve compliance in the marketplace in a proportionate manner’. “ Also see: https://www.medicpro.london/cbd-regulation-laws-uk/
The Cannabis Trades Association:
According to their web site, The Cannabis Trades Association, previously known as The Hemp Trades Association UK Limited, as of September 2018, represents around 900 members (and growing) and around 3000 sellers from 19 EU states, America and Canada making it the largest body of its kind anywhere in the world. In 2018 its members sold around $1.7bn of products worldwide and around €480m of products in Europe.
According to the CTA “in June 2017, the Food Standards Agency (FSA) contacted the CTA as it was intending to review the status of CBD extracts and placing them under the Novel Foods Regulation (CBD has been on the Novel Register since 2014). Classifying CBD extracts as Novel Foods, and not food supplements anymore, would create a very restrictive control on how CBD products could be offered to the market, thus stopping the sales of an industry that had witnessed a 100% growth in the previous 6 months.”
“The CTA responded by triggering a series of meetings with the FSA and the head of the Novel Foods section. The goal was to objectively demonstrate that CBD products were historically not Novel and that the need to restrict their sales through demanding regulation was not appropriate. The CTA also insisted on the difference between extracts and isolates. While extracts are obtained using centuries-old methods, isolates use modern technology that did not exist prior to 1997 in order to achieve significantly usable results.”
The CTA continued at its web site: “The CTA and FSA quickly reached a shared position that only saw isolated cannabinoids as Novel Foods, leaving extracts under the foods supplement rules. This successful conclusion ensured on one side that the industry could continue to thrive and grow while selling extracts-based products; it also ensured, on the other side, that the FSA could set its rules and regulations in partnership with a knowledgeable body. This event also raised consciousness about the need of a true self-regulating organisation for the CBD market. The Cannabis Products Directive (CPD), now evolved into TrustCanna, was born. Of course, since then further actions in Europe have seen a tightening from the position we faced then. Now we are dealing extensively with the FSA and other equivalent bodies on a legal route to ensure that non-exclusive cannabinoid extracts are not seen as Novel. October will see the CTA launch a legal process to ensure that only isolated cannabinoid compounds are seen as Novel.”
(NOTE: The inconsistencies between what the CTA’s position, and the positions of the MHRA and the Home Office, which are described in detail earlier in this memorandum. The inconsistencies, relate in part to the virtual impossibility of getting THC concentrations down to below 1 milligram per saleable quantity of CBD extracted product.)
Also see: Stop Notices Novel Foods and Local Councils. At that portion of its web site, the CTA states: “In December 2018, a London Borough Trading Standards officer issued a Stop Notice to a CTA member under Novel Foods. This was apparently first of its kind in the UK. This notice risked placing a newly established member out of business, just a few weeks after opening in a prominent and visible location. It was also a negative precedent for the industry that should not be allowed to be set. The CTA engaged its legal team and helped the member while addressing the local Trading Standards worries. The local Trading Standards officer lifted the stop notice and the member could resume business operations. The CTA has since helped other members in similar situations with Trading Standards. The stop notices were rescinded in all cases.
The CTA is the only organisation of its kind that has since become proactive and is now training Trading Standards officers, with the goal of preventing stop notices based on lack of knowledge.”
On September 2, 2019, the CTA issued the following press release:
“Following the changes to the Novel Foods Regulations and the uncertainty as to if the scope of the regulations would include all cannabinoids and extracts of cannabis. The Cannabis Trades Association is opposed to submitting a Novel Foods Application covering these extracts. Embarking on this application process would mean that the products detailed, within any products, would have to come off the market until such a time as an authorization is granted as the transitional measures to allow the continued sale ended on the 1st Jan 2019. The Cannabis Trades Association would like to confirm:
- It is our opinion that cannabis extracts are not novel
- There have been no legally binding determinations on the status of cannabis extracts and their Novel Food status
- All statements pertaining to the Novel status made by the European Food Standards Agency and Member States are currently only opinion
- Any opinions made by the EFSA cannot be legally relied upon to secure a prosecution for breach of the NFR
- The Novel Food Regulations state it is the Food business operator’s responsibility to determine a food falls within the scope of the Regulation
- We put forward that there is no requirement to submit an application for a Novel Food as it’s our opinion cannabis extract are not Novel
- The risk of submission of an application could result in products coming off the market until such a time as an authorization is granted.“
“While there is no need for Novel Foods applications to be made for cannabis extracts, there is a real need within the industry for legal clarification that extracts are not Novel. As such, following discussions with the EFSA and SANTE, we are proposing a legal route to reach a final determination which has the backing of several Member States in this course of action, all of whom have been visited personally. As part of this process, which is a legal and fully verified action, the CTA will ask all committee members of the Novel Foods Working Group to agree to a process by which it would be unlawful to proceed with any enforcement action against any CTA member. As such, ensuring that only products and sellers registered with the Association are proven to be by the legal team’s opinion safe and legal. We will provide data to every EU member state to show that our members are selling compliantly and that their products are fully compliant with what we believe is not a Novel Food. As another part of the process, we will also introduce TrustCanna, an independent expert panel regulating and registering sellers and products to the Member States. TrustCanna already has a number of companies and products going through registration. TrustCanna is a Cannabis Product certification process that certifies that a product is safe, legal and as described. TrustCanna aims to provide consumers with a single register of all products that will enable them to make informed purchasing decisions from safe ethical suppliers of cannabis products. From farmers, to producers, manufacturers and resellers. Any business in the supply chain can register and TrustCanna certify their products as compliant. Comments may be sought from:
Robert Jappie, Head of Cannabis Law, Mackrell Turner – 020 7240 0521 Hugh McKeown, CEO TrustCanna 07946 253523.” According to Reed Smith “Accordingly, in England, local authorities will have the power under the Novel Foods (England) Regulations 2018 to seize and inspect suspected unauthorised novel foods and issue compliance and stop notices requiring a product to be removed from sale – for instance, when there is reason to suspect it could be harmful to consumers – and to impose fines. The European Food Standards Agency, which is responsible for food safety in the European Union, is currently considering the first novel food application for CBD.”
6. The Centre for Medicinal Cannabis
The Centre for Medicinal Cannabis is an association in the UK composed of numerous medical and scientific professionals and others involved in the area of Medicinal Cannabis. In the area of CBD, in order to support our members, active in the CBD wellness sector, the CMC undertook the most thorough analysis of the UK CBD market to date. The CMC states that it found that the market was much larger than had previously been suggested, larger than that of vitamin C and D combined, and had great potential for growth. Through testing, the CMC also discovered that the quality of products varied wildly. It is also the view of the CMC that inaccurate information is being circulated in this sector leading to confusion over what is actually legal.
I quote a number of comments from the summary to the study. I agree with virtually all of the comments in the study, in the areas where I have some knowledge.
Extracts from the Report:
- “Pure CBD is legal in the United Kingdom and is not classed as a controlled substance. However the CBD industry is engaged with a product that can (and often does) touch on what is permissible under the criminal law, as a result of other elements within the same product.”
- “Many CBD retailers in the UK are trading according to a folk interpretation of domestic law governing controlled substances that is incorrect; however, this is not surprising because the law is complex, and legal clarity – though sought repeatedly – has not been provided.”
- “Common misreadings of the law regarding CBD are a major and widespread problem in the UK CBD sector that undermines the industry and can mislead consumers.”
- “Beyond the legal status of the product under the UK’s existing drugs laws, certain CBD products are also subject to domestic law in respect of rules governing food, or cosmetics, where legal status is determined by a separate set of factors.”
- “Any product containing CBD that is used for medicinal purposes is a medicine and must have a product license, CBD products must therefore avoid making any medical claim or act as a medicinal product by virtue of its presentation, its claims or its composition or face enforcement by the MHRA.”
- “The legal framework that now impacts CBD products is decades old, and the applicable regulations were enacted in 2001 – long before the emergence of a mass consumer market in cannabidiol products. The laws have not been affected by the wider changes enacted for the recent legalisation of cannabis-based medicinal products.”
- “The most important new legal development arises from the European Union’s Novel Food regime, which led to the classification of all extracted cannabinoids as “novel” in
January 2019. As currently drafted, it presents a serious challenge to the CBD market as it exists in the UK today – however it is yet to be enforced in the UK.”
- All cannabinoids for human and animal consumption exist within a regulated regime, with varying levels of restriction. The CBD market in the UK is under-regulated, and this poses challenges for the industry and consumers.
- “Regulations governing CBD products are not specific to cannabidiol, and there is no separate regulatory pathway that has been designed for these products in the UK.”
(Not clear to me what this means.)
- “The CBD industry, like any consumer market, is subject to a range of generic regulations governing food, cosmetics and medicines, and the end product category determines the rules by which those products can be produced, distributed and marketed.”
- “The regulators have clear roles depending on the product category, and their remits are designed not to overlap – so what is a medicine, cannot be a food, for example.” (I disagree with this statement, although it is somewhat correct.)
- “Regulators have not provided clarity on recent developments relating to cannabidiol and this has perpetuated the uncertainty about which products are compliant, and what is to be expected by way of enforcement action for companies breaching the law.”
- “For the first time, robust public attitudes data reveals a high level of CBD use in the UK, consistent with the size of the market estimated in the sector analysis, and demonstrating that CBD has now gone mainstream in the UK.“
- “Two new surveys conducted in May and June 2019 by Dynata and YouGov indicates that between 8- 11% of UK adults respectively – approximately 4-6 million people – have tried CBD. The CBD consumer base is broad – and there is familiarity and recent use among a sizeable proportion of all age groups and social classes.”
- “Those who had consumed cannabis to help alleviate symptoms of any kind were significantly more likely than the group as a whole to have used CBD products in the last year – almost 6 times more likely. Overall, 7% of the population have used cannabis for medicinal purposes in the past year, rising to 41% among those who have used CBD in the past year. And support for legalisation of cannabis increases from 47% among the total population to 75% among past year CBD users.
- “Consumers have clear preferences that drive their buying decisions, and prioritise quality and purity over origin or legality. Clear labelling information and advice on use and consumption tips, followed by a preference for British produced CBD products, were the purchasing priorities that scored highest, more than price, brand or organic status.”
- “User comments supplied for this project reflected a similar theme – that CBD is effective for them, and should be made more widely available, however costs was raised as a factor.”
- “A sizeable proportion of regular CBD users are deriving – or claiming to experience – a medicinal or therapeutic benefit from the CBD they buy. However, consumers are unable to access good quality and impartial information about CBD products in the UK at present.”
- “To date, estimates of the size and nature of the CBD market in the UK have not been comprehensive or robust. Without an accurate picture of how UK consumers are buying CBD, in what product categories, where and for what reason, it is difficult to devise effective policy and proportionate regulations.”
- “For this project, the CMC commissioned an independent market insight and research agency to conduct a bespoke piece of market sizing analysis for the CBD sector in the UK.”The headlines of that research – published in this report – demonstrate how large and important the CBD market already is and that it is rapidly growing.”
- “The size of the UK CBD market is between 3-6 times larger than previous well quoted estimates (£300M per year vs £100M (Brightfield report) and 1.3 M users vs 250K users (CTA) depending on which measure you take; value or users. This is larger than the total UK Vitamin D (£145M) and Vitamin C market (£119M) combined.”
- “The market is currently growing at double digits and expected to be just short of £1B in 2025. This would be equivalent to the entire UK herbal supplement market in 2016.”
- “Over 70% of UK consumers are purchasing tinctures/oils or capsules suggesting a desire to use products systemically and at higher “therapeutic doses” for CBD. In addition, those users from the CBD user panel, with a presumed medically orientated usage, are spending on average 2-3 times a month more (£55 vs £25) than the general population, on these formulations.”
- “The majority of UK consumers of CBD products are purchasing them online, and not in High Street stores, despite their wide availability in pharmacies, health food stores, and supermarkets.”
- “The research also reveals that UK consumers are currently paying high prices for CBD products, with buying habits driven by a range of motivations.”
- “A key conclusion of this analysis is that politicians and policy-makers must now approach the question of how to regulate CBD proportionately in the knowledge that the UK already has millions of regular CBD consumers, not a few tens of thousands.”
|Author: Joshua Neilly|